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FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Sponsor: Bicara Therapeutics
Summary
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Official title: A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2025-01-28
Completion Date
2029-07
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Ficerafusp alfa
Investigational
Pembrolizumab (KEYTRUDA®)
Immunotherapy agent used in combination with investigational agent
Placebo
Placebo Control
Locations (231)
University of Alabama Hospital (Site # 0137)
Birmingham, Alabama, United States
Mayo Clinic Hospital (Site #0147)
Phoenix, Arizona, United States
UC San Diego Moores Cancer Center (Site #0107)
La Jolla, California, United States
UCLA Department of Medicine - Hematology/Oncology (Site #0106)
Los Angeles, California, United States
UC Davis (Site#0144)
Sacramento, California, United States
University of California San Francisco (Site #0130)
San Francisco, California, United States
Stanford Cancer Institute (Site #0150)
Stanford, California, United States
Rocky Mountain Cancer Centers, LLP (Site #0122)
Aurora, Colorado, United States
Rocky Mountain Regional VAMC (Site #0124)
Aurora, Colorado, United States
University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Site#0121)
Aurora, Colorado, United States
ChristianaCare Helen F. Graham Cancer Center and Research Institute (Site # 127)
Newark, Delaware, United States
Mayo Clinic Florida (Site #0148)
Jacksonville, Florida, United States
Cancer Care Centers of Brevard (Site #0136)
Palm Bay, Florida, United States
Moffit Cancer Center (Site #0105)
Tampa, Florida, United States
Captain James A Lovell Federal Health Care Center-VA North Chicago (Site # 133)
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics (Site#0140)
Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc. (Site #0149)
Westwood, Kansas, United States
University of Kentucky, Markey Cancer Center (Site # 109)
Lexington, Kentucky, United States
Norton Cancer Institute (Site#0111)
Louisville, Kentucky, United States
The University of Louisville, James Graham Brown Cancer Center (Site#0115)
Louisville, Kentucky, United States
University of Maryland Medical Group (Site #0112)
Baltimore, Maryland, United States
Massachusetts General Hospital (Site #0131)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (Site#0101)
Boston, Massachusetts, United States
University of Michigan (Site # 161)
Ann Arbor, Michigan, United States
Site #0156
Maplewood, Minnesota, United States
Mayo Clinic Cancer Center - Rochester (Site #0146)
Rochester, Minnesota, United States
Washington University School of Medicine (Site #0114)
St Louis, Missouri, United States
Hackensack Meridian Health (Site # 119)
Hackensack, New Jersey, United States
Rutgers- Cancer Institute (Site #0145)
Newark, New Jersey, United States
Mount Sinai (Site #0155)
New York, New York, United States
Memorial Sloan Kettering Cancer Center (Site#0142)
New York, New York, United States
Duke University Health System (Site#0118)
Durham, North Carolina, United States
Mercy Hospital (Site#0154)
Canton, Ohio, United States
University of Cincinnati Cancer Institute (Site#0117)
Cincinnati, Ohio, United States
University Hospitals Seidman Cancer Center (Site #0151)
Cleveland, Ohio, United States
Cleveland Clinic (Site #0108)
Cleveland, Ohio, United States
Providence Portland Medical Center (Site #0113)
Portland, Oregon, United States
UPMC Hillman Cancer Center (Site #0103)
Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System (Site #0123)
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute (Site #0132)
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC) (Site#0104)
Charleston, South Carolina, United States
SCRI-Oncology Partners (Site#0126)
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center (Site #0116)
Nashville, Tennessee, United States
MD Anderson Cancer Center (Site#0102)
Houston, Texas, United States
SCRI- Texas Oncology- Central South (Site #0152)
Waco, Texas, United States
University of Virginia (Site#0134)
Charlottesville, Virginia, United States
Virginia Commonwealth University (VCU) Massey Cancer Center (Site #0129)
Richmond, Virginia, United States
Richmond Department of Veterans Affairs (Site #0138)
Richmond, Virginia, United States
Swedish Cancer Institute - North Campus Edmonds (Site # 0160)
Edmonds, Washington, United States
Swedish Cancer Institute (Site # 0159)
Seattle, Washington, United States
University of Washington - Seattle Cancer Care Alliance (Site #0125)
Seattle, Washington, United States
Northwest Cancer Specialists, PC (Site#0120)
Vancouver, Washington, United States
William S. Middleton Memorial Veteran's Hospital (Site #0141)
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics (Site #0157)
Madison, Wisconsin, United States
Advocate Aurora Research Institute (Site # 0153)
Milwaukee, Wisconsin, United States
CEMIC (Site # 2301)
Buenos Aires, Argentina
ICM Center (Site # 2306)
Buenos Aires, Argentina
Hospital Universitario Austral (Site # 2303)
Pilar, Argentina
Sanatorio de la Mujer (Site # 2305)
Rosario, Argentina
Hospital Provincial del Centenario (Site # 2302)
Santa Fe, Argentina
Chris O'Brien Lifehouse (Site#0302)
Camperdown, New South Wales, Australia
Nepean Hospital (Site #0306)
Kingswood, New South Wales, Australia
Calvary Mater Newcastle (Site#0304)
Waratah, New South Wales, Australia
Gold Coast University Hospital (Site #0305)
Southport, Queensland, Australia
John Flynn Private Hospital (Site#0307)
Tugun, Queensland, Australia
Austin Health (Site #0303)
Heidelberg, Victoria, Australia
Peter Macallum Cancer Centre (Site#0301)
North Melbourne, Victoria, Australia
Fiona Stanley Hospital (Site#0308)
Murdoch, Western Australia, Australia
Hematology and Medical Oncology, Paracelsus Medical University (Site #1602)
Salzburg, Austria
Medical University Vienna (Site #1601)
Vienna, Austria
AZ St-Jan Brugge Oostende av (Campus Sint-Jan) (Site #1007)
Bruges, Belgium
CHU Ambroise Paré (Site #1005)
Mons, Belgium
CHU UCL Namur, Site Ste. Elisabeth (Site #1002)
Namur, Belgium
CHU UCL Namur, Site Mont-Godinne (Site #1003)
Namur, Belgium
Vitaz (Site #1001)
Sint-Niklaas, Belgium
ZAS Augustinus (Site #1006)
Wilrijk, Belgium
AFECC Hospital Santa Rita de Cassia (Site # 2420)
Santa Cecília, Vitoria ES, Brazil
Hospital de Amor de Barretos - Fundação Pio XII (Site # 2413)
Barretos, Brazil
Centro de Tratamento Oncologico (Site # 2421)
Belém, Brazil
CIONC-Centro Integrado de Oncologia de Curitiba (Site # 2404)
Curitiba, Brazil
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará (Site # 2414)
Fortaleza, Brazil
Oncosite - Centro de Pesquisa Clinica e Oncologia (Site # 2402)
Ijuí, Brazil
Fundação Doutor Amaral Carvalho (Site # 2411)
Jaú, Brazil
Liga Norte-Rio-Grandense Contra o Câncer (Site # 2422)
Natal, Brazil
Hospital de Clínicas de Passo Fundo (Site # 2419)
Passo Fundo, Brazil
Hospital Nossa Senhora da Conceicao (Site # 2403)
Porto Alegre, Brazil
Grupo Oncoclínicas (Site # 2412)
Rio de Janeiro, Brazil
Hospital Ana Nery (Site # 2415)
Santa Cruz do Sul, Brazil
Oncoclinicas do Brasil Serviços Médicos S.A - Oncocentro BH (Site # 2401)
Santa Lúcia, Brazil
Centro de Oncologia do ABC - Unidade Santo Andre (Site # 2410)
São Caetano do Sul, Brazil
Centro Integrado de Pesquisa do Hospital de Base de São José do Rio Preto/FUNFAR (Site # 2406)
São José do Rio Preto, Brazil
Instituto do Cancer do Estado de Sao Paulo (ICESP) (Site # 2417)
São Paulo, Brazil
A. C. Camargo Cancer Center (Site # 2409)
São Paulo, Brazil
IBCC Núcleo de Pesquisa e Ensino (Site # 2405)
São Paulo, Brazil
Oncoclínicas - SP (Site # 2416)
São Paulo, Brazil
Hospital Santa Marcelina (Site # 2418)
São Paulo, Brazil
BC Cancer - Vancouver (Site #0202)
Vancouver, British Columbia, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame (Site #0203)
Montreal, Quebec, Canada
Sunnybrook Health Sciences Centre (Site # 0204)
Toronto, Canada
Fakultni Nemocnice Hradec Kralove (FNHK) (Site # 2101)
Hradec Králové, Czechia